CN110548201A - Injection device - Google Patents
Injection device Download PDFInfo
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- CN110548201A CN110548201A CN201910849164.4A CN201910849164A CN110548201A CN 110548201 A CN110548201 A CN 110548201A CN 201910849164 A CN201910849164 A CN 201910849164A CN 110548201 A CN110548201 A CN 110548201A
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- Prior art keywords
- injection
- needle
- injection site
- injection device
- dose adjustment
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- 238000002347 injection Methods 0.000 title claims abstract description 425
- 239000007924 injection Substances 0.000 title claims abstract description 425
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/206—With automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
the disclosed embodiments disclose an injection device. The injection device is configured to be loaded with a syringe and a needle including a cartridge, or with a cartridge and a needle, the injection device comprising: an injection site holder configured to hold epidermal and subcutaneous tissue of an injection site; a host connected to the injection site holder and configured to automatically perform an injection procedure on the secured injection site. The injection device can fix the epidermis and the subcutaneous tissue of an injection part, so that the puncture depth of the needle head does not enter the muscular tissue as far as possible, thereby facilitating injection and reducing the pain of a user; and it can carry out the injection process automatically, has reduced the operation degree of difficulty for the user that the injection experience is not enough also can conveniently carry out the injection process high-efficiently.
Description
Technical Field
The present disclosure relates to an injection device, and more particularly, to an injection device for use with a syringe or for use with a cartridge and a needle.
background
China is the world with the most diabetes patients, the number of the diabetes patients is increased every year, and currently, 1.1 hundred million diabetes patients exist in China, and the number is 9000 ten thousand in 2011. According to the forecast of the world health organization, the number of Chinese diabetics will increase from 1.1 to 1.5 billion by 2040 years without taking urgent action to reduce life style related risk factors such as unhealthy diet and sedentary and lack of physical exercise. At the same time, China also dies in the countries with the largest number of diabetes patients, and the main reason is that the treatment rate and the control rate of the diabetes patients in China are low. According to survey data of diabetes and urology departments of the Chinese medical society, the standard reaching rate of blood sugar of diabetics treated by insulin in China is only 37%, and insulin injection and injection technology are not standard according to medical rules, so that the method is the main reason for low standard reaching rate of blood sugar control of the diabetics in China.
early treatment with insulin is necessary because of the relative insufficient insulin secretion or insulin resistance in diabetic patients. Insulin injection can temporarily allow hypofunction of islet B cells to rest just as if the patient needs to rest. Some diabetics, after a period of treatment, will have some degree of recovery of islet B cell function, and some may even reduce or stop insulin injections. The insulin treatment can reduce blood sugar, avoid the toxicity of oral drugs to liver and kidney, and reduce or delay the occurrence of complications.
With the continuous progress of the technology, the insulin pen is more and more convenient to use, the needle head becomes thinner and thinner, the pain feeling of injection is smaller and smaller, and the cost is lower and lower. Even so, most diabetics will choose to take hypoglycemic drugs to control blood sugar rather than inject insulin, mainly for two reasons: on one hand, the patient has fear to the needle, the diabetic needs 1 to 4 times of subcutaneous injection every day, and the pain and fear of each injection make many diabetic to be forbidden to insulin injection; on the other hand, the normative requirement of insulin injection on the operation of the insulin pen is higher, and many middle-aged and elderly diabetics are difficult to finish accurate operation due to poor eyesight, and cannot independently use the insulin injection pen to finish injection. In addition, the thickness of the subcutaneous tissue varies from site to site in the body, and the injection method varies. If the injection method is not standard, not only the pain of injection is increased, but also the inaccurate amount of the insulin injection can be caused, the blood sugar fluctuation amplitude is larger, and complications can also appear in advance.
In addition to insulin injections, other frequent subcutaneous injection procedures also present the problems described above.
Disclosure of Invention
there is therefore a need for an injection device that addresses the above problems in the prior art. There is a need for an injection device that can be used in conjunction with an injector including a cartridge and a needle or a cartridge and a needle, and that can fix the epidermis and subcutaneous tissue of the injection site so that the needle penetration depth does not enter the musculature as much as possible, thereby facilitating injection and reducing pain for the user; and it can carry out the injection process automatically, has reduced the operation degree of difficulty for the user that the injection experience is not enough also can conveniently carry out the injection process high-efficiently.
According to a first aspect of the present disclosure, there is provided an injection device configured to enclose a syringe and a needle comprising a cartridge, or enclose a cartridge and a needle. The injection device comprises: an injection site holder configured to hold epidermal and subcutaneous tissue of an injection site; a host secured to the injection site holder and configured to automatically perform an injection procedure on the secured injection site.
In some embodiments, the injection site holder comprises: at least one of a negative pressure suction mechanism and a mechanical squeezing mechanism; an accommodating portion configured to: receiving and fixing the epidermis and the subcutaneous tissue of the injection site by the at least one of the negative pressure suction mechanism and the mechanical pressing mechanism, and providing an opening to expose at least a part of the epidermis and the subcutaneous tissue of the received and fixed injection site; a height-limiting portion configured to: limiting the height of the at least a portion of the epidermal and subcutaneous tissue of the exposed injection site.
in some embodiments, where the injection site holder includes at least the negative pressure aspiration mechanism, the injection device further includes a pressure detector configured to detect pressure applied by the injection site holder to the injection site.
In some embodiments, the host further comprises a micro-control unit configured to: receiving a signal from the pressure detector indicating the magnitude of the pressure, and sending a pressure maintenance signal to the injection site holder if the pressure is within a preset range.
in some embodiments, the injection site holder is configured to: the accommodating part is disc-shaped and the cross section of the accommodating part is arched; and/or the height limiting part is arranged outside the opening; and/or the height limiter comprises an inward extension.
In some embodiments, where the injection site holder comprises at least the negative pressure aspiration mechanism, the injection device further comprises a needle sealing mechanism configured to seal between the needle and the injection site holder.
in some embodiments, the host further comprises: a first drive mechanism configured to drive an injection in response to an injection drive signal; a second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle penetration drive signal; a micro-control unit configured to: and receiving a signal indicating the pressure from the pressure detector, and sending the acupuncture driving signal to the second driving mechanism and the injection driving signal to the first driving mechanism successively under the condition that the pressure is in a preset range.
In some embodiments, the syringe is provided with a dose adjustment mechanism or the host is provided with a dose adjustment mechanism, the host further comprising: a dose adjustment detection mechanism configured to detect an operational state of the dose adjustment mechanism and to transmit a corresponding dose adjustment indication signal; wherein the micro control unit is further configured to: receiving the dose adjustment indication signal, allowing actuation of the injection site holder to perform a fixation if the dose adjustment indication signal indicates that a dose adjustment has been made.
in some embodiments, the first drive mechanism is connected to a dose adjustment mechanism of the syringe or a dose adjustment mechanism on the host, and the operational state of the dose adjustment mechanism includes whether a dose adjustment has been made, whether the needle is blocked, and whether the dose adjustment mechanism has been pushed back to a zero position.
in some embodiments, the host further comprises: an in-place detection mechanism configured to: detecting whether the syringe and the needle are assembled in place in the case that the injection device is configured to be loaded with the syringe and the needle, and detecting whether the cartridge and the needle are assembled in place in the case that the injection device is configured to be loaded with the cartridge and the needle, and transmitting corresponding in-place detection signals; wherein the micro control unit is configured to: receiving the in-place detection signal, allowing actuation of the injection site holder to perform a fixation if the in-place detection signal indicates fitting in place.
In some embodiments, the host further comprises: an in-place detection mechanism configured to: detecting whether the syringe and the needle are assembled in place in the case that the injection device is configured to be loaded with the syringe and the needle, and detecting whether the cartridge and the needle are assembled in place in the case that the injection device is loaded with the cartridge and the needle, and transmitting corresponding in-place detection signals; an injection key configured to send an activation signal when depressed; wherein the micro control unit is further configured to: upon receipt of the activation signal, actuating the dose dial detection mechanism and the in-place detection mechanism to perform a test; actuating the injection site holder to perform a fixation in case the in-place detection signal indicates fitting in place and the dose adjustment indication signal indicates that a dose adjustment has been made.
In some embodiments, the host further comprises: a first drive mechanism configured to drive an injection in response to an injection drive signal; a second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle penetration drive signal; an injection key configured to send an activation signal when depressed; a micro-control unit configured to: in response to the activation signal, sending the needle stick drive signal to the second drive mechanism if the injection site satisfies a needle stick activation condition.
In some embodiments, the needle stick initiation condition comprises at least one of: in the case where the injection site holder includes at least the negative pressure suction mechanism, the pressure inside the injection site holder is within a preset range and can be maintained; where the injection site holder comprises a mechanical compression mechanism, the mechanical compression mechanism completes the injection site fixation.
in some embodiments, the second drive mechanism is further configured to: driving the needle to reset in response to a reset driving signal; the micro control unit is further configured to: upon satisfaction of an injection complete condition, actuating the injection site holder to perform a release and then sending the reset drive signal to the second drive mechanism.
In some embodiments, the injection completion condition comprises at least one of: the dose adjustment mechanism returns to a zero position and the dwell time of the needle in the subcutaneous tissue reaches a set threshold; alternatively, needle occlusion is detected.
in some embodiments, the injection device, when configured to enclose a syringe and needle, further comprises a first cap, a second cap, and a third cap removably connected to the host,
wherein the first cover is configured to: in a disassembled state, the injector is loaded into the host; the second cover is configured to: in the disassembly state, the needle head is used for loading or disassembling; the third cover is configured to: is detachably connected to a side of the second cover opposite to the first cover, and exposes the receiving part of the injection site holder in a detached state.
In some embodiments, the injection device, when configured to contain a cartridge and a needle, further comprises a second cap and a third cap removably connected to the host, wherein the second cap is configured to: in the disassembly state, the pen core and the needle head are used for loading or disassembling; the third cover is configured to: is detachably connected to a side of the second cover opposite to the main body, and exposes the receiving part of the injection site holder in a detached state.
In some embodiments, where the injection site holder includes at least the negative pressure aspiration mechanism, a needle sealing mechanism and the injection site holder are provided within the second cover, the needle sealing mechanism assembling the needle in an airtight manner upon closing the second cover, effecting an airtight seal of the needle relative to the injection site holder.
Utilize according to the injection device of each embodiment of this disclosure, can use with syringe and syringe needle or refill and the cooperation of syringe needle including the refill, the puncture of convenient syringe needle reduces user's painful sense, and automatic injection process, has reduced the dependence to user's experience, ensures that each suitable injection position at the health can both conveniently carry out the injection process high-efficiently, and the cost is lower, the facilitate promotion.
Drawings
in the drawings, which are not necessarily drawn to scale, like reference numerals may describe similar components in different views. Like reference numerals having letter suffixes or different letter suffixes may represent different instances of similar components. The drawings illustrate various embodiments generally by way of example and not by way of limitation, and together with the description and claims serve to explain the disclosed embodiments. The same reference numbers will be used throughout the drawings to refer to the same or like parts, where appropriate. Such embodiments are illustrative, and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.
Fig. 1 shows a schematic view of an injection device according to an embodiment of the present disclosure;
Fig. 2(a) and 2(b) show illustrations of a first example of an injection site holder in an injection device according to an embodiment of the present disclosure in a natural state and a suction state of an injection site, respectively;
fig. 3(a), 3(b) and 3(c) show illustrations of a second example of an injection site holder in an injection device according to an embodiment of the present disclosure in a natural state, a squeezed state, and a squeezed and attracted state of an injection site, respectively;
FIG. 4 shows a cross-sectional view of an injection device according to an embodiment of the present disclosure;
Fig. 5 shows an external schematic view of an injection device according to an embodiment of the present disclosure;
fig. 6(a), 6(b) and 6(c) show schematic views of an injection device according to an embodiment of the present disclosure with the first, second and third caps detached, respectively;
Fig. 7 shows an exemplary injection flow diagram using an injection device according to an embodiment of the present disclosure;
Fig. 8 shows an external schematic view of an injection device according to an embodiment of the present disclosure;
Fig. 9 shows a schematic view of how an injection device according to an embodiment of the present disclosure is fitted with a cartridge and a needle; and
Fig. 10 illustrates an exemplary injection flow diagram using an injection device according to an embodiment of the present disclosure.
Detailed Description
For a better understanding of the technical aspects of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawings. Embodiments of the present disclosure are described in further detail below with reference to the figures and the detailed description, but the present disclosure is not limited thereto.
the use of "first," "second," and similar terms in this disclosure is not intended to indicate any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element preceding the word covers the element listed after the word, and does not exclude the possibility that other elements are also covered. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.
In the present disclosure, when a specific device is described as being located between a first device and a second device, there may or may not be intervening devices between the specific device and the first device or the second device. When a particular device is described as being coupled to other devices, that particular device may be directly coupled to the other devices without intervening devices or may be directly coupled to the other devices with intervening devices.
All terms (including technical or scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs unless specifically defined otherwise. Note that in this context the technical term "injector" means an injection device that does not comprise a needle, such as an insulin injection pen or the like with the needle removed. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate.
fig. 1 shows a schematic view of an injection device according to an embodiment of the present disclosure. As shown in fig. 1, the injection device 100 is configured to load a syringe 107 including a cartridge 108 and a needle 106 or to load a cartridge 108 (instead of the syringe 107) and a needle 106. The injection device 100 includes: an injection site holder 101 configured to hold an epidermis 103 and a subcutaneous tissue 104 of an injection site; and a host 102 (only a partial cross-sectional view of which is shown in fig. 1) secured to the injection site holder 101 and configured to automatically perform an injection procedure on the secured injection site. The injection site holder 101 may be placed at the injection site before injection, and when injection is to be initiated, an external force may be applied to the injection site using the injection site holder 101, thereby fixing the epidermis 103 and the subcutaneous tissue 104 of the injection site therein. As shown in fig. 1, since the epidermis 103 and the subcutaneous tissue 104 are in a shallower position than the muscle tissue 105, are lower in density than the muscle tissue 105, and are significantly stronger in softness and mobility than the muscle tissue 105, under the external force of the injection site holder 101, the epidermis 103 and the subcutaneous tissue 104 mainly enter and are held by the injection site holder 101, and the muscle tissue 105 rarely enters therein, so that it is possible to ensure that the penetration depth of the needle 106 is limited within the fixed subcutaneous tissue 104 and does not enter into the muscle tissue 105, thereby facilitating the penetration of the needle 106 and also significantly reducing the pain of the user; also, by fixing and pressing the epidermis 103 and the subcutaneous tissue 104, slippage and deformation thereof at the time of needling are reduced, so that the needling operation can be controlled more precisely.
the injection site holder 101 may take various implementations.
For example, the structure of the first example shown in fig. 2(a) and 2(b), respectively, may be employed. As shown in fig. 2(a) and 2(b), the injection site holder 200 may include: a negative pressure suction mechanism (not shown) to generate negative pressure; an accommodating portion 203 configured to: receiving and securing epidermal and subcutaneous tissue 204 of the injection site by negative pressure and providing an opening to expose at least a portion of the received and secured epidermal and subcutaneous tissue 204 of the injection site; and a height-limiting portion 202 configured to: the height of the at least a portion of the epidermal and subcutaneous tissue 204 of the exposed injection site is limited. With the raised portion 202, it is possible to provide allowance for the rise of the epidermis and the hypodermis 204 under the negative pressure (as shown in fig. 2 (b)), to control the puncture depth more precisely, and to avoid the needle 205 from unintentionally penetrating the exposed epidermis and hypodermis 204 except for the penetration and injection, that is, to make the needle 205 only penetrate the epidermis and the hypodermis 204 at a proper depth actively and intentionally, but not "passively" due to the rise of the epidermis and the hypodermis 204, thereby improving the safety of the injection process.
In addition to the negative pressure suction mechanism, the injection site holder 101 may also employ a mechanical pressing mechanism, or may also combine the negative pressure suction mechanism and the mechanical pressing mechanism (not shown), as shown in fig. 3(a), 3(b), and 3(c), and the accommodating portion 303, the height limiter 302, and the epidermis and the subcutaneous tissue 304 may be similar to the accommodating portion 203, the height limiter 202, the epidermis and the subcutaneous tissue 204 in fig. 2(a) and 2(b), respectively, and will not be described in detail herein. As shown in fig. 3(a), the injection site holder 300 may be placed on the injection site such that the end of the receiving portion 303 contacts the epidermis. In some embodiments, a mechanical compression mechanism may be secured to the receptacle 303 and configured to collapse the receptacle 303, as shown in fig. 3(b), thereby applying pressure to the epidermal and subcutaneous tissue 304 housed within the receptacle 303. A negative pressure suction mechanism (not shown) is then activated to further receive and secure the epidermal and subcutaneous tissue 304 of the injection site through the negative pressure effect, as shown in fig. 3 (c). By combining negative pressure suction and mechanical extrusion, the injection part is easier to be fixed, and the applicability is better; the epidermis and the subcutaneous tissue 304 entering the accommodating part 303 are gathered and then are sucked and fixed by the negative pressure, the received drawing tension is smaller, the injection is more facilitated, and the energy consumption of the negative pressure suction mechanism is obviously reduced.
in some embodiments, where the injection site holder includes at least the negative pressure aspiration mechanism, the injection device may further include a pressure detector 305 configured to detect pressure applied by the injection site holder 300 to the injection site. The pressure applied to the injection site can be monitored by the pressure detector 305, and it can be ensured that the pressure is kept within a proper range, and neither too high pressure causes too much tension in the subcutaneous tissue 304 in the injection site holder 300, which would obstruct the needle stick and injection and affect the accuracy of the injected dose, nor too low pressure causes the subcutaneous tissue 304 to be loose, which would make it impossible to precisely control the depth of the needle stick.
In some embodiments, the host 102 may include a micro-control unit 306, and the micro-control unit 306 may be implemented by any one or more of a single chip, a system on a chip (SOC), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), or the like. The micro control unit 306 may be configured to: receives a signal from the pressure detector 305 indicating the magnitude of the pressure, and sends a pressure maintenance signal to the injection site holder 300 in the case where the pressure is within a preset range. That is, the pressure to which the subcutaneous tissue 304 is subjected may be autonomously determined by the micro control unit 306, and if the pressure is within a preset range (i.e., the pressure is appropriate), the injection site holder 300 may be instructed via the pressure maintenance signal to maintain the currently appropriate pressure, so that the pressure may be continuously and stably maintained within the appropriate range so that there is sufficient time to accurately perform the acupuncture and the injection. In some embodiments, the micro-control unit 306 may also issue real-time instructions to adjust the pressure to within a suitable range based on the pressure signal from the pressure detector 305, for example, sending a pressure release signal if the pressure is too high and sending a pressure increase signal if the pressure is too low, thereby enabling dynamic real-time adjustment of the tension of the subcutaneous tissue 304 to ensure accurate control of the depth of penetration and accuracy of the injected dose.
In some embodiments, the injection site holder 101 may be configured as a silicone device, thereby providing more comfort in use and better skin fit. As an example, the accommodating portion 303 may have a disk shape and an arch-shaped cross section, as shown in fig. 3(b) and 3(c), and the disk-shaped and arch-shaped cross section structure conforms to the shape of the epidermis and the subcutaneous tissue 304 after being compressed/sucked, so that the accommodating portion can be better attached to the epidermis and the subcutaneous tissue and the fixing effect can be better. As an example, the elevation 302 may be arranged outside (peripheral) the opening (for penetration by the needle) in order to avoid hindering the penetration by the needle and exposing the injection site to a greater extent.
In some embodiments, the elevation limiter 302 may further include inward extensions (as shown in fig. 3(a) -3 (c)), that is, the elevation limiter 302 may extend at least partially inward (note that the opening for needle penetration is located inside the inward extensions), and these inward extensions may act as a barrier to prevent upward irregular (e.g., intermittent) spillage of the epidermis and subcutaneous tissue 304 after compression/suction, maintain flatness of the surface of the exposed portion, reduce obstruction and interference with needle penetration, and thereby enable more precise control of the subcutaneous penetration depth.
In some embodiments, where the injection site holder includes at least a negative pressure aspiration mechanism (not shown), such as injection site holders 200 and 300, the injection device may further include a needle sealing mechanism, such as 201 or 301, configured to seal between the needle and the injection site holder 200 or 300, thereby preventing air leakage and increasing the efficiency of the negative pressure aspiration.
Fig. 4 shows a cross-sectional view of an injection device according to an embodiment of the present disclosure, and it is noted that fig. 4 incorporates a syringe 404 and a needle 414, but this is by way of example only, and in other embodiments, a cartridge and needle 414 may be incorporated, with slight modifications to the components involved.
As shown in fig. 4, the host 411 may include: a first drive mechanism 403 configured to drive (e.g., injector 404) an injection in response to an injection drive signal; a second drive mechanism 406 configured to drive the needle 414 to penetrate the injection site in response to a needle penetration drive signal; a micro control unit 415 configured to: receives a signal indicating the magnitude of the pressure from a pressure detector (not shown), and sends the needle punching drive signal to the second drive mechanism 406 and the injection drive signal to the first drive mechanism 403 one after another if the pressure is within a preset range. In this way, the micro-control unit 415 can be used to monitor the pressure applied to the injection site in real time, and under the condition that the pressure is proper, that is, the pressure is not too high, so that the tension of the subcutaneous tissue in the injection site fixer 409 is too high, and even the needle injection is blocked or the injection dosage accuracy is affected, and the pressure is not too low, so that the subcutaneous tissue is loosened, so that the needle depth cannot be accurately controlled, the first driving mechanism 403 and the second driving mechanism 406 are automatically controlled to perform the needle injection and the injection operation in sequence without manual intervention. In some embodiments, second drive mechanism 406 may drive needle 414 into the subcutaneous tissue at a suitable depth to avoid piercing muscle tissue causing obstruction and pain.
in some embodiments, the syringe 404 may be provided with a dose adjustment mechanism (e.g., an adjustment knob) 402, and the user may rotate the dose adjustment mechanism 402 to preset a dose to be injected. In the case of loading the cartridge and needle 414, the dose adjustment mechanism 402 may instead be provided on the main body 411. The host 411 may further include: a dose adjustment detection mechanism 401 configured to detect an operational state of the dose adjustment mechanism 402 and to send a corresponding dose adjustment indication signal, as an example, the dose adjustment detection mechanism 401 may be implemented using pressure sensitive elements. Wherein the micro control unit 415 is further configured to: receiving the dose adjustment indication signal, in case the dose adjustment indication signal indicates that a dose adjustment has been made, allowing the injection site holder 409 to be actuated to perform the fixation. It is noted that the expression "in the case of … …, allow" throughout this document is intended to mean: confirmation that a dose adjustment has been made may be a sufficient condition to actuate the injection site holder 409, and in some embodiments may be only a necessary condition for the injection site holder 409, e.g., the injection site holder 409 may be actuated to perform the holding while also satisfying several other conditions, including but not limited to the syringe 404 and needle 414 being assembled in place, the user pressing an injection button to signal injection initiation to the micro control unit 415, etc.
in some embodiments, via the dose adjustment detection mechanism 401, the micro control unit 415 may autonomously identify whether the user has completed adjusting the injected dose, and if not, not initiate any injection step, such as but not limited to injection site fixation, but rather give a prompt via visual or audible means to prompt the user to adjust the injected dose. In this way, ineffective or erroneous injection site fixation, needle stick and injection operation without a preset injection dose can be avoided, thereby saving energy consumption and improving safety.
In some embodiments, the first drive mechanism 403 may be coupled to the dose adjustment mechanism 402 of the syringe 404 such that as the first drive mechanism 403 drives the dose adjustment mechanism 402 of the syringe 404, the dose adjustment mechanism 402 pushes the plunger within the cartridge and correspondingly injects the medicament within the cartridge into the subcutaneous tissue, and the dose adjustment mechanism 402 correspondingly returns to a null position when the preset injection dose is injected into the subcutaneous tissue. In some embodiments, dose adjustment mechanism 402 may instead be provided on host 411 rather than on syringe 404, and first drive mechanism 403 may be coupled to dose adjustment mechanism 402 provided on host 411.
for example, when the dose adjustment mechanism 402 is stuck in a certain non-zero position, then clogging of the needle 414 is likely to occur. In some embodiments, the (operating) state of the dose adjustment mechanism 402 is not limited to whether a dose adjustment has been made, but may also include whether the needle 414 is blocked and the dose adjustment mechanism 402 has been pushed back to a zero position, and the dose adjustment indication signal may also reflect these operating states accordingly. The micro-control unit 415 may send a corresponding control command to control the corresponding component to perform a corresponding operation according to a specific operation state, for example, a status indicator lamp on the exterior of the injection device reminds that the needle 414 is blocked or the injection is completed, activates the injection site fixing position 409 to release the pressure, and then sends a reset driving signal to the second driving mechanism 406 to perform a needle pulling operation, and so on.
In some embodiments, the host 411 may further include: a presence detection mechanism 407 configured to: detects whether the syringe 404 and needle 414 are fitted in place in the case where the injection device is configured to fit the syringe 404 and needle 414 (detects whether the cartridge and needle are fitted in place in the case where the injection device is configured to fit a cartridge and needle), and transmits a corresponding in-place detection signal. Wherein the micro control unit 415 may be configured to: receiving the in-place detection signal, in case the in-place detection signal indicates fitting in place, allows to actuate the injection site holder 409 to perform the holding, such that ineffective or erroneous holding operations can be avoided, thereby saving energy consumption and improving safety.
In some embodiments, a syringe locking mechanism 405 may be disposed within the host 411 and configured to lock and unlock the syringe 404. For example, when the syringe 404 is to be loaded, the syringe locking mechanism 405 may be unlocked in advance, and after the syringe 404 is fitted in place, the syringe locking mechanism 405 may automatically lock it to prevent shaking of the syringe during subsequent needle sticks, injections, and the like, thereby improving the accuracy of the operation. For example, the syringe locking mechanism 405 may be implemented in a variety of ways, such as a snap fit, a magnetic engagement, and the like.
In some embodiments, as shown in fig. 5, the host 511 may also include an injection button 503. An injection button 503 may be exposed from an outer surface of the injection device to facilitate a user's depression and to send an activation signal in response to the depression. Wherein the micro control unit 415 may be further configured to: upon receipt of the activation signal, the dose dial detection mechanism 401 and the in-place detection mechanism 407 are actuated to perform a detection; in case the in-place detection signal indicates that the fitting is in place and the dose adjustment indication signal indicates that a dose adjustment has been made, the injection site holder 409 is actuated to perform the fixing. After the injection site is fixed, as mentioned above, the micro control unit 415 may receive a signal indicating the pressure from a pressure detector (not shown), and sequentially send the needle punching driving signal to the second driving mechanism 406 and the injection driving signal to the first driving mechanism 403 when the pressure is within a preset range, so as to perform needle punching and injection when the injection site is subjected to an appropriate pressure, so as to precisely control the needle punching depth and the accuracy of the injected dose. In some embodiments, the micro control unit 415 may be further configured to: upon satisfaction of the injection completion condition, the injection site holder 409 is actuated to perform pressure release to loosen the epidermis and hypodermis of the injection site, and then the reset drive signal is sent to the second drive mechanism 406 to drive the needle 414 to withdraw from the epidermis and hypodermis of the relaxed injection site, thereby avoiding backflow of the medicament due to tension upon withdrawal of the needle 414 from the tensioned injection site, the loss due to backflow of the medicament being very considerable in the application of minute amounts of medicament such as insulin. Through the process, the injection device can realize the complete injection process of fixing, needling, injecting and pulling out the injection part of one-key type automatic injection with extremely high user friendliness, the user only needs to adjust the dose adjusting mechanism 402 to preset the injection dose as required, the injector 404 and the needle 414 are installed in the injection device, and then the injection button 503 is pressed, the injection device can automatically fix the epidermis and the subcutaneous tissue of the injection part without manual intervention, the pressure born by the epidermis and the subcutaneous tissue is kept in a proper range dynamically, the needling at a proper depth is executed at the same time, the precise injection of the preset injection dose is executed, the epidermis and the subcutaneous tissue of the injection part are loosened, and the needle 414 is conveniently pulled out from the epidermis and the subcutaneous tissue, the operation is simple and convenient, the pain feeling of the user is obviously reduced, and the waste of the medicament is reduced.
in some embodiments, the micro-control unit 415 may also send the needle stick drive signal to the second drive mechanism 406 only if the injection site meets the needle stick enabling condition by performing a determination whether the injection site meets the needle stick enabling condition in response to the enabling signal. In some embodiments, the needle stick initiation condition comprises at least one of: in the case where the injection site holder 409 includes at least the negative pressure suction mechanism, the pressure inside the injection site holder 409 is within a preset range and can be maintained; in case the injection site holder 409 comprises a mechanical pressing mechanism, the mechanical pressing mechanism completes the injection site fixation. Particularly, under the condition of adopting a mechanical extrusion mechanism, the mechanical extrusion mechanism usually adopts inward feeding of the clamping pieces to realize mechanical extrusion, the feeding amount can be preset, the fixation of the injection part is completed only after the feeding amount is completed, the vibration of the acupuncture injection part is started to be small, the precision is high, and acupuncture in the feeding process is avoided. In the case of using the negative pressure suction mechanism, the pressure of the injection site holder 409 is maintained within a predetermined range for a predetermined period of time, and the tension of the subcutaneous tissue at the injection site is not so high as to hinder the acupuncture, and is not so low as to cause the subcutaneous tissue to be loose, thereby facilitating the accurate and precise execution of the acupuncture operation. In the case where the injection site holder 409 incorporates both the negative pressure suction mechanism and the mechanical pressing mechanism, it is possible to determine whether both satisfy the above-described needling start condition, and if so, it is ensured that the fixed state of the injection site is ready to perform needling, and the needling operation is more accurate and precise.
In some embodiments, different injection completion conditions may be set, for example, the injection completion condition may be that the dose adjustment mechanism 402 returns to a zero position (i.e., the preset injection amount has been injected), the needle 414 remains in the subcutaneous tissue for a set threshold amount of time; or it may be that needle occlusion is detected, such as but not limited to dose adjustment mechanism 402 being stuck in a certain non-zero position. By taking into account the abnormal injection completion condition of needle 414 occlusion, needle 414 can be reset and withdrawn with needle 414 occluded, thereby avoiding ineffective injections, waste of medication, and the risk of continuing ineffective injections while needle 414 is occluded.
Fig. 5 shows a schematic external view of an injection device 500 according to an embodiment of the present disclosure, by way of example, the injection device 500 being intended for use with a syringe and a needle, although it may be structurally adapted for use with a cartridge and a needle. As shown in fig. 5, the injection device 500 may include a first cap 510 (identified as 410 in fig. 4), a second cap 512 (identified as 412 in fig. 4), and a third cap 513 (identified as 413 in fig. 4) that are removably connected to the host. Wherein the first cover 510 may be configured to: in a disassembled state (e.g., an open state), for loading the syringe 507 into the host 511 (as shown in fig. 6 (a)) or taking it out of the host 511. The second cover 512 is configured to: in a disassembled state (e.g., an open state), for loading or unloading the needle 508. When the needle 508 is to be removed after the injection is completed, the second cover 512 may be opened (as shown in fig. 6 (b)), the needle cap 514 may be closed to be engaged (screwed or snapped) with the needle 508, and then the needle cap 514 may be held to be unscrewed from the needle 508 and discarded. Thus, loading or unloading of the needle 508 is facilitated, and in particular, the needle 508 is prevented from being touched by the user during unloading, which improves safety and also prevents the needle 508 and the residual medicament therein from contaminating the environment. The third cover 513 may be configured to: is detachably connected to the side of the second cover 512 opposite to the first cover 510, and exposes the receiving part 509 of the injection site holder in a detached state (e.g., an opened state) (as shown in fig. 6 (c)). The first cover 510, the second cover 512 and the third cover 513 may enclose the syringe 507, the needle 508 and the injection site holder, respectively, in a closed state, to prevent contamination by or to the external environment.
In some embodiments, referring to fig. 4, in case the injection site holder 409 comprises at least the negative pressure suction mechanism (not shown), a needle sealing mechanism 408 and the injection site holder 409 may be provided within the second cover 412, the needle sealing mechanism 408 being connected to the needle 414 in an airtight manner when the second cover 412 is closed, achieving an airtight sealing of the needle 414 with respect to the injection site holder 409, thereby enabling a significant increase in the efficiency of use of the injection site holder 409 when at least the negative pressure suction mechanism is employed.
returning to fig. 5, the injection device 500 is also provided with an on/off button 502 and an injection button 503 on the exterior thereof, and the user may turn the injection device 500 on or off by pressing the on/off button 502. In addition, as described above, the user only needs to assemble the syringe and the needle with the set dose, and then presses the injection button 503, the injection device 500 can automatically and accurately and smoothly perform the operations of fixing the injection site, performing acupuncture, injecting and pulling out the needle in sequence, the operation is simple, and the pain of the user is significantly reduced.
the exterior of the injection device 500 may also be provided with an injection dosage window 501, a status indicator light 504, a dosage window 505, and a battery status indicator light 506. The injection dosage window 501 may be used to observe whether the injector has been dose adjusted and the injection dosage after adjustment. The dosage window 505 may be used to view the amount of remaining dosage in the cartridge and the presence of air bubbles to determine if air bubbles need to be removed or a new cartridge replaced. The status indicator lamp 504 allows the user to clearly identify which operation step of all the operation steps of syringe mounting, injection dose adjustment, injection site fixation, etc., the entire injection process has proceeded to, and/or further indicates the execution status of each operation step, the operation is green if successful, the operation is red if failed, and the corresponding indicator lamp is not lit if the operation step has not been reached. The battery status indicator 506 may be configured to display a mounting status (whether to mount) of the battery and/or a remaining power status of the battery, for example, when the remaining power of the battery is too low, the battery status indicator 506 may be red and flash to indicate that the remaining power is too low and the injection cannot be completed, so as to avoid invalid injection (for example, the injection process is not completed and is interrupted due to insufficient power); for another example, when a battery is not installed, the battery status indicator lamp 506 may be red to indicate to the user that the battery is installed.
fig. 7 illustrates an exemplary injection flow diagram using an injection device according to an embodiment of the present disclosure. The injection process 700 begins at step 701: and opening the syringe dismounting cover, loading the syringe with the refill into a main machine of the injection device, locking, and closing the syringe dismounting cover. This step 701 is typically performed when the injection device is first used or the syringe is replaced with a new cartridge, otherwise it may be skipped. In some embodiments, loading the syringe requires aligning the dose display window of the syringe with a window on the injection device host, and if the two windows are not aligned, the adjusted dose cannot be seen. The syringe may be automatically locked after being loaded in place using a locking mechanism.
At step 702, the needle removal cover is opened, a new needle is installed, and the needle cap is removed. Then, in step 703, the syringe attachment and detachment cap is opened, completing the bubble removal operation. It may be determined whether the needle is clogged by the air bubble operation (step 704) and if so, it may return to step 702 to replace the needle and verify that the needle is clear. If not, then a dose adjustment step 705 is performed, the injection dose may be adjusted by the dose adjustment mechanism of the syringe, and then the syringe cap and needle cap are closed (step 706).
an injection site fixation procedure is then performed. In step 707, the injection cover is opened to expose a receptacle (e.g., injection tray) of the injection site holder. The injection tray may be placed at the injection site and the start injection button pressed (step 708). After the injection starting button is pressed down, a micro control unit in the host machine executes a series of judgments and automatically drives corresponding components to sequentially execute the operations of fixing, needling, injecting and pulling out the needle.
Specifically, at step 709, it is checked whether the syringe is in place (loaded and locked) and, at step 710, it is determined whether the injection dose adjustment mechanism has completed dose adjustment. If the injector is not installed in place, the injection part is not started to be fixed, and the prompt information that the injector is not installed is given through the status indicator lamp to prompt a user to install the injector again. If the dose adjusting mechanism is detected to be in the zero position, the injection part can not be started to be fixed, and the user is prompted to adjust the injection dose through the status indicator lamp. If it is detected that the syringe is in place and dose adjustment has been completed, it continues to be determined in step 711 whether the needle is in place and if so, the injection disc is driven to pressurize to fix the epidermal and subcutaneous tissue at the injection site.
It is determined in step 713 whether the injection site is well fixed, in particular, the pressure in the injection tray may be detected via a pressure sensor, and when the pressure is within a suitable range, it is determined that the injection site is well fixed, and if not, the pressure in the injection tray is adjusted until it is within the suitable range, achieving fixation of the injection site. Next, at step 714, the pressurization is stopped, and the pressure applied to the injection site within the injection tray is maintained substantially constant and the injector is driven to complete the needle stick and injection. Specifically, after the injection site is secured, the micro-control unit of the injection device may issue a needle penetration command to the injector drive mechanism to drive the needle to penetrate the subcutaneous tissue at a rapid rate, and then activate the injection drive mechanism in the syringe cap to smoothly perform the injection until the dose adjustment mechanism of the syringe is pushed to the zero position to complete the injection of the preset dose.
after the injection is completed, the needle is allowed to remain in the subcutaneous tissue for a few seconds and the pressure applied to the injection site is then released (step 715). At step 716, the syringe drive mechanism pushes the syringe to extract the needle and reset the syringe. At step 717, the injection device may be removed from the injection site, the injection cap closed, the needle cover opened, and the needle cap attached to the needle, thereby unscrewing the needle along with the needle cap and discarding the needle in a waste collection cassette. Next, in step 718, the needle cover is closed, and the injection device is stored, completing the injection procedure.
Fig. 8 shows a schematic exterior view of an injection device 800 according to an embodiment of the present disclosure, the injection device 800 being used in conjunction with a cartridge and a needle. As shown in fig. 8, the main body 811 of the injection device 800 may include an on/off button 802, an injection button 803, an injection dosage window 801, a status indicator lamp 804, a dosage window 805, and a battery status indicator lamp 806, which are similar in structure and effect to the on/off button 502, the injection button 503, the injection dosage window 501, the status indicator lamp 504, the dosage window 505, and the battery status indicator lamp 506 of the main body 511 of the injection device 500 in fig. 5, and will not be described herein again.
Unlike the injection device 800 shown in fig. 5, the injection dose adjustment mechanism 807 is not self-contained in the injector, but is disposed within the main body 811 and partially exposed from the housing of the main body 811 so that it can be easily rotationally adjusted by the user from outside the main body 811. Further, the injection device 800 may comprise two caps, a second cap 812 and a third cap 813. The second cap 812 is used for assembling and disassembling the pen core and the needle, and the structure and the effect of the third cap 813 are similar to those of the third cap 513 in fig. 5, and are not described in detail herein.
fig. 9 shows a schematic view of how an injection device 900 according to an embodiment of the present disclosure is equipped with a cartridge 904 and a needle 906. As shown in fig. 9, the injection device 900 may include a second cover 912 and a third cover 913 detachably (e.g., may be opened or closed) connected to a host (not shown), wherein the second cover 912 may be configured to: in a detached (open) state, for loading or unloading the cartridge 904 and the needle 906; the third cover 913 may be configured to: is detachably attached to the side of the second cover 912 opposite to the main body and in a detached state may expose a receiving portion (not shown, similar to that shown in fig. 6 (c)) of an injection site holder.
A removable cartridge mounting 905 may be provided in the injection device 900. The second cap 912 and the third cap 913 may be opened and the cartridge mounting rack 905 may be removed, the cartridge 904 may be assembled to the cartridge mounting rack 905, and the cartridge mounting rack 905 containing the cartridge 904 may be reloaded into the injection device 900 and locked. For example, a securing mechanism and/or a locking mechanism for cartridge mount 905 may be provided within the main body of injection device 900 to facilitate securing and/or locking of cartridge mount 905. In some embodiments, injection device 900 may be provided with a presence detection mechanism 907 configured to detect whether cartridge holder 905 and needle 906 are in place, and if so, and an injection dose is preset and the injection site is properly secured, needle 906 may be actuated to perform a needle stick, then the plunger within cartridge 904 may be actuated to perform an injection of the preset dose, cartridge holder 905 may be actuated to withdraw the needle after the injection is completed, and so on. In some embodiments, a plunger 908 may be disposed on the cartridge 904, the plunger 908 may be actuated by an injection drive mechanism, and the injection drive mechanism may be coupled to the injection dose adjustment mechanism and the plunger 908 within the cartridge 904, such that the injection dose adjustment mechanism rotates the corresponding scale toward the zero position as the plunger 908 is actuated by the injection drive mechanism, and returns to the zero position when the injection is completed.
Fig. 10 shows a flow diagram of an exemplary injection procedure 1000 using an injection device according to an embodiment of the present disclosure. As shown in fig. 10, the injection process 1000 begins with step 1001: opening the refill and the needle head dismounting cover, if the refill is not loaded, loading the refill first, and then loading the needle head on the refill; if the refill is installed, only a new needle is installed. At step 1002, a de-bubbling operation is performed to ensure that the needle is not clogged. At step 1003, after the bubble removal operation is completed, the needle cover may be closed and the dose injected may then be adjusted by the dose adjustment mechanism to preset the dose to be injected.
At step 1004, the injection cap is opened to expose the receiving portion of the injection site holder. Here, a suction cup serving as the housing portion is exposed as an example. At step 1005, the suction cup may be placed at the injection site, the start injection button is pressed, and the entire process of securing, piercing, injecting, and withdrawing the needle is then automatically controlled by the micro control unit within the injection device.
Specifically, when the start injection button is pressed, it is first checked whether the cartridge and the needle are mounted in place (step 1006), and whether the injection dose adjustment is completed (step 1007). If the pen core and the needle head are not installed in place, the injection part is not started to be fixed, and prompt information that the pen core and the needle head are not installed is given through a state indicating lamp to prompt a user to install the pen core and the needle head again. If the injection dosage adjustment is not finished, the injection part can not be started to be fixed, and the user is prompted to adjust the injection dosage through the status indicator lamp. If it is determined that the cartridge and the needle are mounted in place and the injection dose adjustment has been completed, the injection site holder is actuated to hold the epidermis and the subcutaneous tissue of the injection site, for example, pressure may be applied to the injection tray (which may be implemented as a suction cup) to hold the epidermis and the subcutaneous tissue of the injection site in compression within the suction cup (see step 1008). It may be detected by the pressure sensor whether the pressure experienced by the suction cup's inner epidermis and subcutaneous tissue is within the appropriate range, and if so, it is determined that the injection site is well secured (see step 1009), and if not, the applied pressure of the injection site holder is continued to be adjusted until the experienced pressure is within the appropriate range and maintained for subsequent operations.
For example, at step 1010, the micro-control unit of the injection device may issue a needle command to the cartridge drive mechanism, which may drive the cartridge with the needle to penetrate the subcutaneous tissue at a fast speed in view of the cartridge and needle being integrally assembled, and then issue an injection command to the injection drive mechanism, which may push the plunger on the cartridge to inject a preset dose of the medicament into the subcutaneous tissue.
After the injection is completed, the needle may remain in the subcutaneous tissue for a few seconds and then release the pressure applied to the injection site (step 1011). The micro-control unit of the injection device may then issue a needle removal command to the cartridge drive mechanism, which may drive the cartridge along with the needle to remove the needle and reset the cartridge and needle (step 1012).
The injection device can then be removed from the injection site, the injection cap closed, the needle removal cap opened, the needle cap capped to snap fit with the needle, for example, and then the needle cap can be conveniently grasped to remove it along with the used needle and discarded into a waste storage case (step 1013). Thus, the injection device can be stored and the injection can be completed.
moreover, although exemplary embodiments have been described herein, the scope thereof includes any and all embodiments based on the disclosure with equivalent elements, modifications, omissions, combinations (e.g., of various embodiments across), adaptations or alterations. The elements of the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. It is intended, therefore, that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.
The above description is intended to be illustrative and not restrictive. For example, the above-described examples (or one or more versions thereof) may be used in combination with each other. For example, other embodiments may be used by those of ordinary skill in the art upon reading the above description. In addition, in the foregoing detailed description, various features may be grouped together to streamline the disclosure. This should not be interpreted as an intention that a disclosed feature not claimed is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
the above embodiments are only exemplary embodiments of the present invention, and are not intended to limit the present invention, and the scope of the present invention is defined by the claims. Various modifications and equivalents may be made by those skilled in the art within the spirit and scope of the present invention, and such modifications and equivalents should also be considered as falling within the scope of the present invention.
Claims (18)
1. An injection device configured to receive a syringe including a cartridge and a needle, or a cartridge and a needle, the injection device comprising:
An injection site holder configured to hold epidermal and subcutaneous tissue of an injection site;
A host connected to the injection site holder and configured to automatically perform an injection procedure on the secured injection site.
2. The injection device of claim 1, wherein the injection site holder comprises:
At least one of a negative pressure suction mechanism and a mechanical squeezing mechanism;
An accommodating portion configured to: receiving and fixing the epidermis and the subcutaneous tissue of the injection site by the at least one of the negative pressure suction mechanism and the mechanical pressing mechanism, and providing an opening to expose at least a part of the epidermis and the subcutaneous tissue of the received and fixed injection site;
A height-limiting portion configured to: limiting the height of the at least a portion of the epidermal and subcutaneous tissue of the exposed injection site.
3. The injection device of claim 1, wherein where the injection site holder comprises at least the negative pressure aspiration mechanism, the injection device further comprises a pressure detector configured to detect a pressure applied by the injection site holder to the injection site.
4. the injection device of claim 3, wherein the host further comprises a micro-control unit configured to: receiving a signal from the pressure detector indicating the magnitude of the pressure, and sending a pressure maintenance signal to the injection site holder if the pressure is within a preset range.
5. The injection device of claim 1, wherein the injection site holder is configured to:
The accommodating part is disc-shaped and the cross section of the accommodating part is arched; and/or
The height limiting part is arranged on the outer side of the opening; and/or
The height limiter includes an inward extension.
6. The injection device of claim 1, wherein where the injection site holder comprises at least the negative pressure aspiration mechanism, the injection device further comprises a needle sealing mechanism configured to seal between the needle and the injection site holder.
7. The injection device of claim 1, wherein the host further comprises:
a first drive mechanism configured to drive an injection in response to an injection drive signal;
a second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle penetration drive signal;
A micro-control unit configured to: and receiving a signal indicating the pressure from the pressure detector, and sending the acupuncture driving signal to the second driving mechanism and the injection driving signal to the first driving mechanism successively under the condition that the pressure is in a preset range.
8. An injection device according to claim 7, wherein the injector is provided with a dose adjustment mechanism or the host is provided with a dose adjustment mechanism, the host further comprising:
A dose adjustment detection mechanism configured to detect a state of the dose adjustment mechanism and to transmit a corresponding dose adjustment indication signal;
Wherein the micro control unit is further configured to: receiving the dose adjustment indication signal, allowing actuation of the injection site holder to perform a fixation if the dose adjustment indication signal indicates that a dose adjustment has been made.
9. the injection device of claim 8, wherein the first drive mechanism is connected to a dose adjustment mechanism of the syringe or to a dose adjustment mechanism provided on the host, and the state of the dose adjustment mechanism includes whether a dose adjustment has been made, whether the needle is blocked, and whether the dose adjustment mechanism has been pushed back to zero.
10. The injection device of claim 7, wherein the host further comprises:
an in-place detection mechanism configured to: detecting whether the syringe and the needle are assembled in place in the case that the injection device is configured to be loaded with the syringe and the needle, and detecting whether the cartridge and the needle are assembled in place in the case that the injection device is configured to be loaded with the cartridge and the needle, and transmitting corresponding in-place detection signals;
Wherein the micro control unit is configured to: receiving the in-place detection signal, allowing actuation of the injection site holder to perform a fixation if the in-place detection signal indicates fitting in place.
11. The injection device of claim 8, wherein the host further comprises:
an in-place detection mechanism configured to: detecting whether the syringe and the needle are assembled in place in the case that the injection device is configured to be loaded with the syringe and the needle, and detecting whether the cartridge and the needle are assembled in place in the case that the injection device is configured to be loaded with the cartridge and the needle, and transmitting corresponding in-place detection signals;
An injection key configured to send an activation signal when depressed;
Wherein the micro control unit is further configured to: upon receipt of the activation signal, actuating the dose dial detection mechanism and the in-place detection mechanism to perform a test; actuating the injection site holder to perform a fixation in case the in-place detection signal indicates fitting in place and the dose adjustment indication signal indicates that a dose adjustment has been made.
12. The injection device of claim 1, wherein the host further comprises:
A first drive mechanism configured to drive an injection in response to an injection drive signal;
A second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle penetration drive signal;
An injection key configured to send an activation signal when depressed;
a micro-control unit configured to: in response to the activation signal, sending the needle stick drive signal to the second drive mechanism if the injection site satisfies a needle stick activation condition.
13. The injection device of claim 12, wherein the needle stick activation condition comprises at least one of:
In the case where the injection site holder includes at least the negative pressure suction mechanism, the pressure inside the injection site holder is within a preset range and can be maintained;
In case the injection site holder comprises only a mechanical pressing mechanism, the mechanical pressing mechanism completes the injection site fixation.
14. The injection device of claim 8, wherein the second drive mechanism is further configured to: driving the needle to reset in response to a reset driving signal;
The micro control unit is further configured to: upon satisfaction of an injection complete condition, actuating the injection site holder to perform a release and then sending the reset drive signal to the second drive mechanism.
15. The injection device of claim 14, wherein the injection-complete condition comprises at least one of:
the dose adjustment mechanism returns to a zero position;
The retention time of the needle head in the subcutaneous tissue reaches a set threshold value;
Needle blockage is detected.
16. The injection device of claim 2, further comprising first, second, and third caps removably connected to the host when configured to enclose a syringe and a needle,
Wherein the first cover is configured to: in a disassembled state, the injector is loaded into the host;
The second cover is configured to: in the disassembly state, the needle head is used for loading or disassembling;
The third cover is configured to: is detachably connected to a side of the second cover opposite to the first cover, and exposes the receiving part of the injection site holder in a detached state.
17. The injection device of claim 2, further comprising second and third caps removably connected to the host in the case of the injection device configured to receive a cartridge and a needle,
wherein the second cover is configured to: in the disassembly state, the pen core and the needle head are used for loading or disassembling;
The third cover is configured to: is detachably connected to a side of the second cover opposite to the main body, and exposes the receiving part of the injection site holder in a detached state.
18. An injection device according to claim 16 or 17, wherein in the case where the injection site holder comprises at least the negative pressure suction means, a needle sealing means is provided in the second cap and the injection site holder, the needle sealing means being connected to the needle in an airtight manner when the second cap is closed, effecting an airtight sealing of the needle relative to the injection site holder.
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CN201910849164.4A CN110548201A (en) | 2019-09-09 | 2019-09-09 | Injection device |
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CN111939392A (en) * | 2020-07-16 | 2020-11-17 | 深圳市中科微光医疗器械技术有限公司 | Beauty needle automatic injection control method and device and beauty needle |
CN113633850A (en) * | 2021-07-08 | 2021-11-12 | 中国科学院大学宁波华美医院 | Automatic insulin injection device |
CN114470403A (en) * | 2021-12-31 | 2022-05-13 | 深圳瑞宇医疗科技有限公司 | Intelligent injection device capable of being pasted on skin and automatically injecting insulin |
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